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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, endosseous, orthodontic
Regulation Description Endosseous dental implant.
Definition It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Product CodeOAT
Regulation Number 872.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
BERNHARD FÖRSTER GMBH (BERNHARD FOERSTER LTD.)
  SUBSTANTIALLY EQUIVALENT 1
BIOCETEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMATERIALS KOREA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
BOMEI CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRANIOFACIAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GNI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEONE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MK MEDITECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TECHWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZE FANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 38 26
2021 68 53
2022 84 84
2023 78 78
2024 35 44
2025 35 39
2026 17 19

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 311 302
Loss of Osseointegration 15 13
Adverse Event Without Identified Device or Use Problem 13 13
Fracture 11 12
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 162
Fibrosis 147 139
Pain 28 27
Unspecified Infection 22 20
Inflammation 19 19
Tissue Damage 16 15
Hemorrhage/Blood Loss/Bleeding 11 10
Swelling/ Edema 11 9
Failure of Implant 6 0
Hyperresponsive to stimuli 4 4
Hypersensitivity/Allergic reaction 3 3
Inadequate Osseointegration 3 0
Insufficient Information 2 2
Fistula 2 2
Implant Pain 1 1
Sinus Perforation 1 1
Abscess 1 1

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